NCT06104319

Brief Summary

The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2025

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

October 23, 2023

Last Update Submit

October 13, 2025

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

GSK4532990Non-alcoholic steatohepatitis (NASH)Non-alcoholic fatty liver disease (NAFLD)Suspected NASH

Outcome Measures

Primary Outcomes (2)

  • Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels

    Baseline (Day 1) and up to Week 28

  • Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels

    Baseline (Day 1) and up to Week 28

Secondary Outcomes (4)

  • Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990

    Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose

  • Maximum observed concentration (Cmax) of GSK4532990

    Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose

  • Percent change from baseline in the. observed HSD17B13 protein expression. levels

    Baseline and Weeks 8, 12, or 28 post-dose

  • Percent change from baseline in the. observed HSD17B13 mRNA expression. levels

    Baseline and Weeks 8, 12, or 28 post-dose

Study Arms (4)

GSK4532990 Dose 1

EXPERIMENTAL

Participants will receive GSK4532990 Dose 1

Drug: GSK4532990

GSK4532990 Dose 2

EXPERIMENTAL

Participants will receive GSK4532990 Dose 2

Drug: GSK4532990

GSK4532990 Dose 3

EXPERIMENTAL

Participants will receive GSK4532990 Dose 3

Drug: GSK4532990

GSK4532990 Dose 4

EXPERIMENTAL

Participants will receive GSK4532990 Dose 4

Drug: GSK4532990

Interventions

GSK4532990DRUG

GSK4532990 will be administered

GSK4532990 Dose 1GSK4532990 Dose 2GSK4532990 Dose 3GSK4532990 Dose 4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be 18 to 75 years of age.
  • Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
  • Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
  • Participants must meet predefined stable use requirements of concomitant medications based on study criteria.

You may not qualify if:

  • Cirrhosis or current unstable liver or biliary disease.
  • Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.
  • Known weight loss of ≥5% within 3 months prior to Screening.
  • Weight reduction surgery or procedures within 2 years of Screening.
  • Any contraindication to undergoing liver biopsy.
  • Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

GSK Investigational Site

Chula Vista, California, 91911, United States

Location

GSK Investigational Site

Montclair, California, 91763, United States

Location

GSK Investigational Site

San Diego, California, 91911, United States

Location

GSK Investigational Site

San Diego, California, 91942, United States

Location

GSK Investigational Site

Brandon, Florida, 33511, United States

Location

GSK Investigational Site

Miami, Florida, 33155, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Miami Lakes, Florida, 33014, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

El Dorado, Kansas, 67042, United States

Location

GSK Investigational Site

Marrero, Louisiana, 70072, United States

Location

GSK Investigational Site

Austin, Texas, 78745, United States

Location

GSK Investigational Site

San Antonio, Texas, 78215, United States

Location

GSK Investigational Site

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

January 22, 2024

Primary Completion

September 23, 2025

Study Completion

September 23, 2025

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
More information

Locations

US(14)